Outlook Therapeutics, Inc. · tam yanıt mektubu (BLA 761320)

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( Lg my U.S. FOOD & DRUG Ny, ADMINISTRATION BLA 761320 COMPLETE RESPONSE Outlook Therapeutics, Inc. Attention: Jennifer Kissner, PhD Senior Vice President, Clinical and Regulatory Affairs 111 South Wood Avenue Unit #100 Iselin, NJ 08830 Dear Dr. Kissner: Please refer to your biologics license application (BLA) oe or bevacizumab-vikg injection. (b) (4) , action letter. We acknowledge receipt of your amendment dated constituted a complete response to our om , which We have completed our review of this application, as amended, and have determined that we cannot approve this application in its present form. We have described our reasons for this action below and, where possible, our recommendations to address these issues. There is a lack of substantial evidence consisting of adequate and well-controlled investigations, as defined in § 314.126, that the product will have the effect it purports or is represented to have under the conditions of use prescribed, recommended, or suggested in its proposed labeling. NORSE 2 met its primary endpoint for effectiveness. In NORSE EIGHT, !®) (bevacizumab-vikg) injection did not meet the primary efficacy endpoint of mean change from baseline in ETDRS BCVA score at the Week 8 visit in comparison to ranibizumab using a non-inferiority margin of -3.5 letters. Therefore, there is not sufficient evidence to demonstrate that by (bevacizumab-vikg) 1.25 mg is noninferior to ranibizumab 0.5 mg dosed monthly to treat wet-AMD. It is recommended

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